BEUDAMED
    FDA Enforcement Class II Ongoing

    FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

    Recall: Z-0106-2026 · Reported October 15, 2025

    Enforcement

    Recall Number
    Z-0106-2026
    Event ID
    97565
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Inpeco S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 15, 2025
    Initiation Date
    September 3, 2025
    Classification Date
    October 9, 2025
    Address
    Via San Gottardo 10, Lugano, N/A, Switzerland

    Description

    FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

    Reason

    The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.

    Code Info

    PN: FLX-056-01, FLX-056-11; UDI: 07640172340004: Serial No. FLX.0204, FLX.0205, FLX.0209, FLX.0210, FLX.0216, FLX.0220, FLX.0221, FLX.0222.

    Distribution

    US distribution to CA & NY.

    Quantity

    8 units